Back to resultsStudy to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis (PROMPT)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dimethyl fumarate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Relapsing remitting Multiple Sclerosis
Eligibility Criteria
Key Inclusion Criteria:
- Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
- Multiple sclerosis (MS) onset within one year before enrolment
- ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
- No previous disease modifying and/or immunosuppressive treatments for MS.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Exclusion Criteria:
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
- Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
- History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
- History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
- An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BG00012
Placebo
Arm Description
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
Placebo capsules orally twice a day.
Outcomes
Primary Outcome Measures
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)
Secondary Outcome Measures
Mean number of CUA
Mean number of hypointense T1 lesions
New Gd+ lesions
New/enlarging T2 lesions
Full Information
NCT ID
NCT02472938
First Posted
May 11, 2015
Last Updated
December 23, 2015
Sponsor
Biogen
Collaborators
GB Pharma Services & Consulting s.r.l.
1. Study Identification
Unique Protocol Identification Number
NCT02472938
Brief Title
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
Acronym
PROMPT
Official Title
Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor Decision
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
GB Pharma Services & Consulting s.r.l.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Relapsing remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG00012
Arm Type
Experimental
Arm Description
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules orally twice a day.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
DMF, Tecfidera, BG00012
Intervention Description
dimethyl fumarate 120 mg capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for BG00012
Primary Outcome Measure Information:
Title
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Mean number of CUA
Time Frame
at 4, 8, 12, 16, 20 and 24 weeks
Title
Mean number of hypointense T1 lesions
Time Frame
at 24 weeks
Title
New Gd+ lesions
Time Frame
at 4, 8, 12, 16, 20 and 24 weeks
Title
New/enlarging T2 lesions
Time Frame
at 4, 8, 12, 16, 20 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
Multiple sclerosis (MS) onset within one year before enrolment
≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
No previous disease modifying and/or immunosuppressive treatments for MS.
Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Exclusion Criteria:
Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
We'll reach out to this number within 24 hrs